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Recall Observatory FDA recall evidence

Device product

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059

Z-0615-2019

September 13, 2018

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 81151
Status
Terminated
Classification
Class II
Quantity
17550 cartridges
Official record key
device-enforcement:Z-0615-2019

Official wording

Reason: Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated

Code information: Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233

Distribution pattern: WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated